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  1. Development & Approval Process (Drugs)

Clinical Outcome Assessment (COA) Qualification Program

Clinical Outcome Assessment (COA) Qualification Program

The CDER Clinical Outcome Assessment (COA) Qualification Program:

  • Manages the qualification process for COAs intended to address unmet public health needs.
  • Works directly with requestors in guiding COA development for qualification.
  • Encourages a collaborative, multidisciplinary setting where CDER can review COAs and provide advice on the development or modification of COAs outside the IND/NDA/BLA pathway.

COA Qualification:

COA qualification is a regulatory conclusion that the COA is a well-defined and reliable assessment of a specified concept of interest for use in adequate and well-controlled (A&WC) studies in a specified context of use. COA qualification represents a conclusion that within the stated context of use, results of assessment can be relied upon to measure a specific concept and have a specific interpretation and application in drug development and regulatory decision-making.

If you have questions about the CDER COA Qualification Program, please email: COADDTQualification@fda.hhs.gov

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